Primary Device ID | 00860001672725 |
NIH Device Record Key | af01931c-eee0-4223-aff0-06ecb1440921 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ClearCalc |
Version Model Number | 2.0 |
Company DUNS | 080444608 |
Company Name | Radformation, Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860001672725 [Primary] |
MUJ | System, Planning, Radiation Therapy Treatment |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-10-19 |
Device Publish Date | 2021-10-11 |
00860001672725 - ClearCalc | 2021-10-19ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations are accurate using an independent Monitor Unit (MU) and dose calculation algorithm. |
00860001672725 - ClearCalc | 2021-10-19 ClearCalc is a software intended to assist radiation treatment planners in determining if their treatment planning calculations |
00860001672732 - AutoContour | 2021-10-19 AutoContour is intended to assist radiation treatment planners in contouring and reviewing structures within medical images in p |
00860001672701 - ClearCheck | 2021-10-12 ClearCheck is intended for quality assessment of radiotherapy treatment plans. |
00860001672718 - EZFluence | 2021-10-12 EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homoge |
00860001672749 - ChartCheck | 2021-10-12 ChartCheck assists in quality assessment of radiotherapy treatment plans and on treatment chart review utilizing treatment, imag |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEARCALC 88886825 not registered Live/Pending |
Radformation, Inc. 2020-04-24 |
CLEARCALC 87789566 5560991 Live/Registered |
ClearGage, LLC 2018-02-08 |